Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)

ConditionsIBS Ulcerative Colitis, Active Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms)Healthy Controls Crohn's Disease, Active Crohn's Disease, Remission (6a: With IBS Symptoms, 6b: Without IBS Symptoms)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorKU Leuven

About this trial

Aim:

More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Irritable Bowel Syndrome (IBS) (ROME III criteria)

No obvious organic explanation for the IBS symptoms

Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study

diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)

Disqualifiers

co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting

Abdominal chirurgy (except for an uncomplicated appendectomy)

Trial design

Design model

Single group

Treatments tested in this trial

Sample collection
Other intervention
Collection of blood, feces samples, sample of nasal mucosa and biopsies (rectum and colon descendens), questionnaires and performance of rectal sensitivity measurement (barostat), MR scan of brain and transit measurement of colon

Treatment groups

99,999,999 Participants

are divided into 1 treatment group

Group A: Sample collectionOther 1 intervention

Trial outcomes

Primary outcomes

differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)

Visceral sensitivity will me measured by performing a rectal barostat test

Time frame

at time of investigation (rectal barostat test), Day 1

Secondary outcomes

immune activity (measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood)

measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood (for example by stimulating Peripheral Blood Mononuclear Cells)

Time frame

at time of investigation (rectal biopsy), Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KU Leuven

Lead sponsor

Source ClinicalTrials.gov

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